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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
| Wenzhou Medical University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Xijing Hospital |
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This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cetuximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 Month Complete Response Rate + Partial Response Rate | According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| One-year locoregional control rate | locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region. | 1 year |
| Three-year locoregional control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao | Sun Yat-sen University | Principal Investigator |
| Yunfeng Zhou | Zhongnan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
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| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| OTHER |
| Hunan Cancer Hospital | OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Wuhan University | OTHER |
| Hubei Cancer Hospital | OTHER |
| Tongji University | OTHER |
| Affiliated Cancer Hospital of Shantou University Medical College | OTHER |
| Shenzhen People's Hospital | OTHER |
| First People's Hospital of Foshan | OTHER |
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locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
| 3 years |
| One-year disease free survival rate | disease free survival rate: from the time when finish treatment to first failure at any site. | 1 year |
| Three-year disease free survival rate | disease free survival rate: from the time when finish treatment to first failure at any site. | 3 years |
| One-year overall survival rate | overall survival rate: from the time when finish treatment to death of any cause. | 1 year |
| Three-year overall survival rate | overall survival rate: from the time when finish treatment to death of any cause. | 3 years |
| The relationship between 3 years overall survival rate and expression of EGFR | all patients must have sufficient pretreatment tumor biopsy specimens. | 3 years |
| Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life | collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished. | 3 years |
| The relationship between 3 years overall survival rate and amplification of EGFR | all patients must have sufficient pretreatment tumor biopsy specimens. | 3 years |
| The relationship between 3 years overall survival rate and mutation of EGFR | all patients must have sufficient pretreatment tumor biopsy specimens. | 3 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |